None listed
Conditions
Brief summary
This study looks at the effectiveness and safety of treatment with the herb ginkgo biloba in preventing or reducing changes in thinking, memory and concentration (cognitive function) experienced by some women after treatment for early breast cancer. Who is it for? You can join this study if you have been diagnosed with early invasive breast cancer and you have had surgery for this, and have completed primary adjuvant treatment. What does it involve? Participants will be divided into two groups. One group will receive treatment with standardized extracts of the herb ginkgo biloba. The other group will receive a non-active compound (placebo). Both groups will take two tablets (120mg) of study treatment each day for a period of 6 months. All participants will have their cognitive function monitored, along with fatigue, quality of life, blood tests, other possible symptoms, Assessments are at baseline, 6 and 12 months after randomization. Each assessment will take approximately 90 minutes. Most women who receive chemotherapy become tired; some complain of memory & concentration problems. Studies have found subtle cognitive impairment ("chemobrain") that can disturb the return to a normal life and there are no known treatments. Ginkgo biloba has been shown to improve cognition in healthy younger volunteers & improve cognition & mood, without side effects, in elderly people.
Interventions
Ginkgo Biloba (standardised extract EGB 761) encapsulated tablets
Dose: 240 mg (2x120 mg) encapsulated tablets taken daily
Duration: 6 months
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of invasive breast cancer for which definitive surgery was performed. Patient has completed chemotherapy and/or radiotherapy and/or targeted therapy for adjuvant treatment (if received) for breast cancer at least six months previously. Patients who did not require chemotherapy are eligible but must be at least six months post surgery and radiotherapy. Patient has completed at least 2 months of anti-cancer hormonal treatment (if received). Patient is less than two years post completing primary adjuvant treatment. Self report cognitive symptoms based on a Single Item Question assessing their subjective change in cognitive function since their cancer diagnosis. Participants must select one of three possible responses (yes, no, unknown) to the question: “Do you think your brain is working as well as it was before your cancer diagnosis?” To meet eligibility, participants must choose the “NO” response. Speak fluent English and read to at least year 8 standard; Written informed consent; Accessible for treatment and follow-up
Exclusion criteria
Eastern Cooperative Oncology Group (ECOG) performance status < or = 2; Any evidence of extra-nodal metastatic disease; Any major pre-existing psychiatric history or dementia, alcohol abuse, current use of psychotropic medication that might lead to cognitive problems other than benzodiazepines for nausea or sleep or selective serotonin reuptake inhibitor (SSRI) for hot flashes; Pre-existing neurological condition or any other co-morbidity which may interfere with their ability to perform cognitive testing; Previous chemotherapy for a malignancy. Life expectancy < 2years; use of Ginkgo biloba within 4 weeks of randomisation; Any contraindication to taking ginkgo biloba.
Outcome results
None listed